Three major trials will test the effectiveness of cannabidiol (CBD) as a psychosis treatment following a £16.5 million funding injection.
Wellcome has awarded Oxford’s Department of Psychiatry £16.5m for the STEP (Stratification & Treatment in Early Psychosis) programme as part of its support for mental health research. The programme will include 1,000 participants to understand whether CBD could be an effective psychosis treatment.
According to the NHS website, psychosis is when people lose some contact with reality. The two main symptoms are hallucinations and delusions. Hallucinations cause a person to hear, see and, in some cases, feel, smell or taste things that do not exist outside their mind, and delusions cause a person to have strong beliefs that are not shared by others.
Widening treatment options for psychosis patients
The programme involves 35 centres globally and will be coordinated by the Prince of Wales International Centre for SANE Research. Jazz Pharmaceuticals have supplied the cannabidiol for the trials at no cost.
Professor McGuire said: “Cannabidiol is one of the most promising new treatments for people with psychosis. This study will be the first to evaluate cannabidiol in large numbers of people with psychosis or psychotic symptoms and brings together many of the leading centres working in this area around the world.
“Many people with psychosis are open to trying cannabidiol, and previous smaller-scale studies have indicated that it has beneficial effects. As well as treating psychosis that is already established, the study will also investigate whether cannabidiol can prevent the onset of psychosis in people at high risk of developing it.
“This study could provide us with a new kind of treatment for psychosis, and we are hugely grateful to Wellcome and Jazz Pharmaceuticals for helping to make it happen.”
What is cannabidiol?
The cannabidiol used in the study is extracted from the cannabis plant. It is more than 99% cannabidiol. The common adverse psychoactive effects found in the cannabis plant have been removed. The form of cannabidiol being used in the study is the same as the cannabidiol called Epidyolex, which has been approved for use to treat seizures in children.
Lynsey Bilsland, Head of Mental Health Translation at Wellcome, said: “This exciting programme will help us to find out if cannabidiol is effective at treating psychosis at various stages by testing it at scale.
“While antipsychotics are commonly used to treat psychosis, they can have significant side effects, patients often stop taking them, and they don’t work for everyone. This means that it is important that we explore avenues such as this one for new therapies.
“In addition, as part of these trials, the researchers are aiming to identify biomarkers – biological signposts – which would indicate that a patient might respond well to the treatment. This will allow for greater personalisation of treatment in the future.”
Following 1,000 participants requiring psychosis treatment
Participants will be assessed before and after treatment using a range of clinical, digital, cognitive, neuroimaging and blood measures to understand how cannabidiol acts to produce its effects and to identify factors that predict the response to psychosis treatment.
The clinical trials will split the participants into one group that will be treated with a placebo, and one group will receive cannabidiol. The medications will be administered alongside the standard psychosis treatment.